NCT05079932

Brief Summary

This project is a pilot study exploring the effects of dietary choices and quantitative digestion of gluten ingested by individuals with IBD compared to a control population. The aim of the study is to evaluate for the first time in an Italian population of subjects with IBD the presence of a diet based on GFD (gluten free diet).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

September 23, 2021

Last Update Submit

October 4, 2021

Conditions

Inflammatory Bowel Diseases

Keywords

Ulcerative rectocolitisCrohn DiseaseGluten-free dietIBDNutrition

Outcome Measures

Primary Outcomes (1)

  • Dietary habits in IBD patients

    Quantification of gluten intake by IBD patients compared with the control population. Evaluation of foods excluded from the diet of IBD patients.

    April 2021- April 2023

Secondary Outcomes (4)

  • Assessment of weight

    April 2021- April 2023

  • Assessment of height

    April 2021- April 2023

  • Assessment of clinical disease activity

    April 2021- April 2023

  • Assessment of clinical disease activity

    April 2021- April 2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 patients with IBD (15 CD and 15 RCU) and 15 patients from the control population

You may qualify if:

  • Age: 18 years
  • Gender: women and men
  • Patients who have been diagnosed with IBD for at least 12 months
  • patients who have signed an informed consent

You may not qualify if:

  • Pregnancy status
  • Patients not suffering from the two main forms of IBD, i.e. CD or RCU (unclassified IBD colitis, collagenous colitis, lymphocytic colitis will be excluded).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

RECRUITING

Related Publications (6)

  • Weaver KN, Herfarth H. Gluten-Free Diet in IBD: Time for a Recommendation? Mol Nutr Food Res. 2021 Mar;65(5):e1901274. doi: 10.1002/mnfr.201901274. Epub 2020 Jun 28.

    PMID: 32558265RESULT

  • Mazzeo T, Roncoroni L, Lombardo V, Tomba C, Elli L, Sieri S, Grioni S, Bardella MT, Agostoni C, Doneda L, Brighenti F, Pellegrini N. Evaluation of a Modified Italian European Prospective Investigation into Cancer and Nutrition Food Frequency Questionnaire for Individuals with Celiac Disease. J Acad Nutr Diet. 2016 Nov;116(11):1810-1816. doi: 10.1016/j.jand.2016.04.013. Epub 2016 May 28.

    PMID: 27245762RESULT

  • Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.

    PMID: 3317057RESULT

  • Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials? Inflamm Bowel Dis. 2012 Nov;18(11):2056-62. doi: 10.1002/ibd.22879. Epub 2012 Jan 23.

    PMID: 22271464RESULT

  • Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.

    PMID: 6102236RESULT

  • Elli L, Bascunan K, di Lernia L, Bardella MT, Doneda L, Soldati L, Orlando S, Ferretti F, Lombardo V, Barigelletti G, Scricciolo A, Fabiano S, Vecchi M, Roncoroni L. Safety of occasional ingestion of gluten in patients with celiac disease: a real-life study. BMC Med. 2020 Mar 16;18(1):42. doi: 10.1186/s12916-020-1511-6.

    PMID: 32172690RESULT

MeSH Terms

Conditions

Inflammatory Bowel DiseasesProctocolitisCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisProctitisColonic DiseasesSigmoid DiseasesRectal Diseases

Study Officials

  • Luca Elli, PhD

    Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Vecchi, doctor

CONTACT

0255033418maurizio.vecchi@policlinico.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 15, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

May 31, 2024

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations

IT(1)